Effect of Rosuvastatin and Eicosapentaenoic Acid on Neoatherosclerosis: The LINK-IT Trial
|ClinicalTrials.gov Identifier: NCT03192579|
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : January 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Progression||Drug: EPA and high dose rosuvastatin Drug: Standard dose rosuvastatin||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Consecutive patients with stent implantation who were performed coronary angiography and OCT follow-up of the coronary arteries were screened. The patients with neoatherosclerosis were randomly assigned to either 2.5-5mg/day of rosuvastatin therapy or 10mg/day(up to 20mg) of rosuvastatin and 1800mg/day of eicosapentaenoic acid therapy at a 1:1 ratio for 12 months.|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Effect of Rosuvastatin and Eicosapentaenoic Acid on Neoatherosclerosis: The LINK-IT Trial|
|Actual Study Start Date :||July 26, 2013|
|Actual Primary Completion Date :||June 2, 2017|
|Actual Study Completion Date :||June 2, 2017|
Experimental: Standard lipid lowering therapy
Start with only rosuvastatin 2.5mg and up to 20mg/day
Drug: Standard dose rosuvastatin
After randomization, patients with standard lipid lowering therapy start only rosuvastatin (2.5mg/day) for 12 months.
Other Name: rosuvastatin
Active Comparator: Intensive lipid lowering therapy
Start EPA and rosuvastatin 10mg/day and up to 20mg/day
Drug: EPA and high dose rosuvastatin
After randomization, patients with intensive lipid lowering therapy start EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for 12 months.
- Lipid index change between baseline and 12 month follow-up [ Time Frame: Baseline and 12 month follow-up ]Lipid core arc was measured by every 0.2-mm interval throughout segments with NA on OCT findings. The mean lipid core arc was calculated for each lesion. Then, the lipid index was calculated by multiplying the mean lipid core arc by the lipid core longitudinal length.
- Macrophage grade change between baseline and 12 month follow-up [ Time Frame: Baseline and 12 month follow-up ]Macrophage arc were measured on OCT images with NA every 0.2-mm intervals and divided 4 groups as follows: grade 0, no mac¬rophage; grade 1, localized macrophage accumulation (<30°); grade 2, clus¬tered accumulation ≥30° and <90°; grade 3, clus¬tered accumulation ≥90° and <270°; and grade 4, clustered accumulation ≥270° and <360° . Macrophage grade was evaluated as summation of 0 to 4 grades across all cross section in NA.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192579
|Study Chair:||Hiromasa Otake, ph.D||Kobe University Graduate School of Medicine|